jRCTs031240073招募中不适用
A comparative pharmacokinetic study of carbamazepine when taken with water and thickened water in healthy adult males.
未提供0 个研究点目标入组 6 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 6
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized Controlled Trial
- 干预模型
- Crossover Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 45age old not(—)
- 性别
- Male
入选标准
- •Age: The applicant must be at least 20 years old and less than 45 years old at the time of obtaining consent.
- •Gender: Male
- •Who have the capacity to give consent, abide by the rules of compliance during participation in the research, and are able to undergo the pre-test specified in the research protocol, and report subjective symptoms, etc.
- •Those who have been judged eligible for participation in this study by the pysician in charge of the research or othewe relevant personnel based on a preliminary examination as stipulated in the research protocol.
排除标准
- •Persons with a medical history (drug abuse/dependence, alcohol abuse/dependence, heart, liver, kidney, lung, eye, or blood disease, etc.) that may affect the evaluation and safety of this study.
- •Persons with hypothyroidism or a history of such disorders.
- •Persons with epilepsy or other convulsive disorders or a history of such disorders.
- •Persons with dysuria or ocular hypertension, etc.
- •Persons taking medications (including supplements and dietary supplements) that may affect the
- •evaluation and safety of this study.
- •Persons with a history of drug allergy.
- •Persons who regularly use excessive amounts of alcohol (those who cannot maintain abstinence from alcohol during the study period)
- •Those who wish their partner to become pregnant during the study period.
- •Persons with a history of drug eruptions caused by carbamazepine in the individual or their family.
- •Those who are within three months of participating in another clinical research study.
- •Any other person who judges by the investigator to be ineligible for the study.
结局指标
主要结局
-
Pharmacokinetic parameters of Carbamazepine in Primary Outcome serum (AUC0-24,Cmax)
次要结局
未报告次要终点
研究者
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